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DISEASE & TREATMENT SETTING

Breast Cancer

Source-derived catalogue. This is not a treatment recommendation or a personalised trial match.

Exact scope

Breast Cancer

Source population
Not part of this definition
Disease extent
Not part of this definition
Treatment line
Not part of this definition
Stage
Not part of this definition
Resectability
Not part of this definition
Biomarkers, prior therapy and derivation
molecular
    prior therapy
      derivation status
      unresolved
      derivation note
      Derived from NCI topic(s): Breast Cancer; Breast Cancer Treatment During Pregnancy. Strongest NCIt resolution: ambiguous. Entity-level scope; stage, biomarker and treatment line are not yet part of this definition.
      source wording
      Source null
      137 more-specific settings
      Etcamah: metastatic Breast cancer with HR stated without a specific alteration, HER2 stated without a specific alteration, ESR1 mutation →Arimidex: Breast cancer (adjuvant) →Enhertu: unresectable metastatic Breast cancer with HER2 positive, HER2 stated without a specific alteration after prior therapy →Femara: Breast cancer (adjuvant) →Femara: Breast cancer with HR positive →Ibrance: metastatic Breast cancer with HER2 negative →Perjeta: locally advanced Breast cancer with HER2 positive (neoadjuvant) →Taxotere: metastatic Breast Carcinoma (adjuvant) →Tykerb: metastatic Breast cancer with HR positive, HER2 stated without a specific alteration →Xeloda: metastatic Breast cancer →Avastin: metastatic Breast cancer with HER2 negative →Tecentriq: unresectable metastatic Breast cancer with PD-L1 stated without a specific alteration →Docetaxel: metastatic Breast cancer after prior therapy →Itovebi: metastatic Breast cancer with PIK3CA stated without a specific alteration, HR stated without a specific alteration, HER2 stated without a specific alteration (adjuvant) af →KADCYLA: Breast cancer with HER2 positive (neoadjuvant) after prior therapy →ABRAXANE: metastatic Breast cancer (adjuvant) after prior therapy →Enhertu: Breast cancer with HER2 positive (neoadjuvant) after prior therapy →FASLODEX: metastatic Breast cancer with HR positive, HER2 negative after prior therapy →Nerlynx: Breast cancer with HER2 positive (adjuvant) →CLIGAVYX: metastatic Breast cancer with HR positive, HER2 negative after prior therapy →IXEMPRA: metastatic Breast cancer after prior therapy →Paclitaxel: metastatic Breast cancer (adjuvant) after prior therapy →Ibrance: metastatic Breast cancer with HER2 Positive, HR positive, HER2 positive (maintenance) after prior therapy →Inluriyo: metastatic Breast cancer with HER2 stated without a specific alteration, ESR1 stated without a specific alteration after prior therapy →TRUQAP: metastatic Breast cancer with HR positive, HER2 negative, HR stated without a specific alteration, HER2 stated without a specific alteration, PIK3CA stated without a specif →TYKERB: metastatic Breast cancer with HER2 stated without a specific alteration after prior therapy →Ellence: Breast cancer (adjuvant) after prior therapy →OGIVRI: Breast cancer with HER2 stated without a specific alteration (adjuvant) after prior therapy →Verzenio: metastatic Breast cancer with HR stated without a specific alteration, HER2 stated without a specific alteration, HR positive, HER2 negative after prior therapy →Doxorubicin Hydrochloride: Breast cancer (adjuvant) after prior therapy →Enhertu: Breast cancer with HER2 stated without a specific alteration, HER2 Positive, HER2 positive (neoadjuvant) →Ibrance: metastatic Breast cancer with PIK3CA stated without a specific alteration, HR positive, HER2 negative (adjuvant) after prior therapy →Afinitor: advanced Breast cancer with HER2 Negative, HER2 negative after prior therapy →Talzenna: metastatic Breast cancer with BRCA stated without a specific alteration, HER2 negative →Inluriyo: metastatic Breast cancer with HER2 negative, ESR1 stated without a specific alteration after prior therapy →MARGENZA: metastatic Breast cancer with HER2 stated without a specific alteration, HER2 positive after prior therapy →Phesgo: locally advanced Breast cancer with HER2 stated without a specific alteration, HER2 positive (neoadjuvant) →ZOLADEX: advanced Breast cancer →Kanjinti: Breast cancer with HER2 stated without a specific alteration (adjuvant) after prior therapy →CLIGAVYX: metastatic Breast cancer with HR positive, HER2 negative after prior therapy →Lynparza: Breast cancer with BRCA stated without a specific alteration, HER2 negative, HER2 stated without a specific alteration (neoadjuvant) after prior therapy →VEPPANU: metastatic Breast cancer with HER2 stated without a specific alteration, ESR1 stated without a specific alteration after prior therapy →Ibrance: metastatic Breast cancer with HR stated without a specific alteration, HER2 stated without a specific alteration after prior therapy →Verzenio: metastatic Breast cancer with HR stated without a specific alteration, HER2 stated without a specific alteration after prior therapy →Docetaxel: Breast cancer (adjuvant) →Ibrance: metastatic Breast cancer with HER2 Negative, HR stated without a specific alteration, HER2 stated without a specific alteration →KISQALI: metastatic Breast cancer with HR positive, HER2 negative after prior therapy →KEYTRUDA: Breast cancer (neoadjuvant) after prior therapy →IXEMPRA: metastatic Breast cancer →Fulvestrant: metastatic Breast cancer with HR positive, HER2 negative after prior therapy →EXEMESTANE: advanced Breast cancer after prior therapy →EXEMESTANE: Breast cancer (adjuvant) after prior therapy →Herceptin: Breast cancer with HER2 stated without a specific alteration →SOLTAMOX: Breast cancer (adjuvant) →BEIZRAY: Breast cancer (adjuvant) →Verzenio: metastatic Breast cancer with HR stated without a specific alteration, HER2 stated without a specific alteration →TUKYSA: unresectable metastatic Breast cancer with HER2 positive, HER2 stated without a specific alteration after prior therapy →Lynparza: metastatic Breast cancer with BRCA stated without a specific alteration, HER2 negative (neoadjuvant) after prior therapy →DATROWAY: unresectable metastatic Breast cancer with PD-L1 stated without a specific alteration →AVGEMSI: metastatic Breast cancer (first-line) after prior therapy →Enhertu: Breast cancer with HER2 Positive, HER2 positive (neoadjuvant) →Kanjinti: Breast cancer with HER2 stated without a specific alteration →CLIGAVYX: advanced Breast cancer with HR stated without a specific alteration, HER2 stated without a specific alteration, HR positive after prior therapy →Nerlynx: metastatic Breast cancer with HER2 positive, HER2 stated without a specific alteration after prior therapy →Trazimera: metastatic Breast cancer →Phesgo: locally advanced Breast cancer with HER2 positive (neoadjuvant) →Phesgo: metastatic Breast cancer with HER2 positive, HER2 stated without a specific alteration →Aromasin: Breast cancer (adjuvant) after prior therapy →CLIGAVYX: advanced Breast cancer with HR stated without a specific alteration, HER2 stated without a specific alteration →ORSERDU: metastatic Breast cancer with HER2 stated without a specific alteration, ESR1 stated without a specific alteration after prior therapy →PIQRAY: metastatic Breast cancer with HR stated without a specific alteration, HER2 stated without a specific alteration, PIK3CA stated without a specific alteration after prior th →ORSERDU: metastatic Breast cancer with HER2 negative, ESR1 stated without a specific alteration after prior therapy →TYKERB: metastatic Breast cancer with HER2 stated without a specific alteration →Enhertu: unresectable metastatic Breast cancer with HER2 positive, HER2 stated without a specific alteration (neoadjuvant) after prior therapy →HERZUMA: metastatic Breast cancer with HER2 stated without a specific alteration (first-line) after prior therapy →Femara: Breast cancer (adjuvant) after prior therapy →Femara: advanced Breast cancer after prior therapy →DATROWAY: unresectable metastatic Breast cancer with HR Positive, HER2 Negative, HR stated without a specific alteration, HER2 stated without a specific alteration after prior ther →HERZUMA: Breast cancer with HER2 stated without a specific alteration →ARIMIDEX: advanced Breast cancer (second-line) after prior therapy →SOLTAMOX: metastatic Breast cancer →Herceptin: metastatic Breast cancer with HER2 stated without a specific alteration (first-line) after prior therapy →BEIZRAY: metastatic Breast cancer after prior therapy →TRUQAP: metastatic Breast cancer with HR stated without a specific alteration, HER2 stated without a specific alteration, PIK3CA stated without a specific alteration (adjuvant) aft →GEMCITABINE: metastatic Breast cancer (first-line) after prior therapy →PACLITAXEL PROTEIN BOUND PARTICLES ALBUMIN BOUND: metastatic Breast cancer (adjuvant) after prior therapy →KEYTRUDA QLEX: Breast cancer (neoadjuvant) after prior therapy →Herceptin Hylecta: Breast cancer with HER2 stated without a specific alteration (adjuvant) after prior therapy →PERJETA: metastatic Breast cancer with HER2 stated without a specific alteration, HER2 positive →FASLODEX: metastatic Breast cancer with HR positive, HER2 negative after prior therapy →OGIVRI: Breast cancer with HER2 stated without a specific alteration →MARGENZA: metastatic Breast cancer with HER2 positive, HER2 stated without a specific alteration after prior therapy →TRODELVY: unresectable metastatic Breast cancer with PD-L1 stated without a specific alteration (first-line) →Ontruzant: Breast cancer with HER2 stated without a specific alteration (adjuvant) after prior therapy →Talzenna: metastatic Breast cancer with BRCA stated without a specific alteration, HER2 negative, HER2 stated without a specific alteration →XELODA: metastatic Breast cancer after prior therapy →TYKERB: metastatic Breast cancer →Kanjinti: metastatic Breast cancer with HER2 stated without a specific alteration (first-line) after prior therapy →Femara: metastatic Breast cancer (first-line) →Trazimera: Breast cancer with HER2 stated without a specific alteration (adjuvant) →Aromasin: advanced Breast cancer after prior therapy →KADCYLA: metastatic Breast cancer with HER2 positive →OGIVRI: metastatic Breast cancer with HER2 stated without a specific alteration (first-line) after prior therapy →Verzenio: Breast cancer with HR stated without a specific alteration, HER2 stated without a specific alteration (adjuvant) →Trazimera: metastatic Breast cancer with HER2 stated without a specific alteration (first-line) →DOCIVYX: Breast cancer (adjuvant) →Herceptin: Breast cancer with HER2 stated without a specific alteration (adjuvant) after prior therapy →KISQALI: Breast cancer with HR stated without a specific alteration, HER2 stated without a specific alteration (adjuvant) →Fareston: metastatic Breast cancer →PERJETA: metastatic Breast cancer with HER2 positive, HER2 stated without a specific alteration →Ontruzant: metastatic Breast cancer with HER2 stated without a specific alteration (first-line) after prior therapy →Enhertu: unresectable metastatic Breast cancer with HER2 Positive, HER2 positive (first-line) →Nerlynx: Breast cancer with HER2 stated without a specific alteration (adjuvant) →Ellence: Breast cancer (adjuvant) after prior therapy →Fulvestrant: metastatic Breast cancer with HR positive, HER2 negative after prior therapy →Enhertu: unresectable metastatic Breast cancer with HER2 Low, HER2 stated without a specific alteration, HR stated without a specific alteration, HER2 low →DOCIVYX: metastatic Breast cancer after prior therapy →Afinitor: advanced Breast cancer with HER2 negative after prior therapy →Itovebi: metastatic Breast cancer with PIK3CA stated without a specific alteration, HR stated without a specific alteration, HER2 stated without a specific alteration (adjuvant) af →Herceptin Hylecta: metastatic Breast cancer with HER2 stated without a specific alteration (first-line) after prior therapy →Fulvestrant: advanced Breast cancer with HR stated without a specific alteration, HER2 stated without a specific alteration, HR positive after prior therapy →KADCYLA: Breast cancer with HER2 positive (neoadjuvant) after prior therapy →Halaven: metastatic Breast cancer →Fulvestrant: advanced Breast cancer with HR stated without a specific alteration, HER2 stated without a specific alteration →Ontruzant: Breast cancer with HER2 stated without a specific alteration →ARIMIDEX: metastatic Breast cancer (first-line) →TRODELVY: unresectable metastatic Breast cancer with HR positive, HER2 negative, HR stated without a specific alteration, HER2 stated without a specific alteration after prior ther →Herceptin Hylecta: Breast cancer with HER2 stated without a specific alteration →Nerlynx: metastatic Breast cancer with HER2 positive, HER2 stated without a specific alteration after prior therapy →KADCYLA: metastatic Breast cancer with HER2 stated without a specific alteration, HER2 positive →recurrent Breast Cancer →metastatic Breast Cancer →localized Breast Cancer →advanced Breast Cancer →Stage 0 Breast Cancer →Stage IV Breast Cancer →Stage III Breast Cancer →

      Study evidence for this setting

      171 linked studies · Applicability is a draft source assessment, not a determination of your eligibility.

      NCT00003830 · Source cited / selected · Scope: narrower

      Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer

      6 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      NCT00005957 · Source cited / selected · Scope: narrower

      Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer

      2 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      NCT00021255 · Source cited / selected · Scope: narrower

      Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

      3 outcome links · 3 safety-group records · 0 quality-of-life measures

      →

      NCT00045032 · Source cited / selected · Scope: narrower

      Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer

      6 outcome links · 3 safety-group records · 0 quality-of-life measures

      →

      NCT00066573 · Source cited / selected · Scope: narrower

      Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast Cancer

      4 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      NCT00066690 · Source cited / selected · Scope: narrower

      Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

      4 outcome links · 3 safety-group records · 0 quality-of-life measures

      →

      NCT00066703 · Source cited / selected · Scope: narrower

      Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

      4 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      NCT00074152 · Source cited / selected · Scope: narrower

      Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer; Chemotherapy as Adjuvant for LOcally Recurrent Breast Cancer

      3 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      NCT00075764 · Source cited / selected · Scope: narrower

      S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer

      4 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      NCT00099437 · Source cited / selected · Scope: narrower

      Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endo

      6 outcome links · 2 safety-group records · 1 quality-of-life measures

      →

      NCT00104650 · Registry condition search · Scope: narrower

      Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates

      6 outcome links · 3 safety-group records · 0 quality-of-life measures

      →

      NCT00248170 · Source cited / selected · Scope: narrower

      Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer

      6 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      NCT00256698 · Source cited / selected · Scope: narrower

      Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

      6 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      NCT00293384 · Registry condition search · Scope: narrower

      Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant

      4 outcome links · 1 safety-group records · 0 quality-of-life measures

      →

      NCT00295646 · Source cited / selected · Scope: narrower

      Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

      6 outcome links · 4 safety-group records · 0 quality-of-life measures

      →

      NCT00310180 · Source cited / selected · Scope: narrower

      Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

      6 outcome links · 4 safety-group records · 0 quality-of-life measures

      →

      NCT00343382 · Registry condition search · Scope: narrower

      Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer

      4 outcome links · 3 safety-group records · 3 quality-of-life measures

      →

      NCT00382070 · Source cited / selected · Scope: narrower

      Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer

      6 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      NCT00408681 · Registry condition search · Scope: narrower

      Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant

      6 outcome links · 1 safety-group records · 0 quality-of-life measures

      →

      NCT00513292 · Source cited / selected · Scope: narrower

      Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery

      6 outcome links · 2 safety-group records · 0 quality-of-life measures

      →

      Indication-specific source history

      Dated source events, not confirmation of current approval for every use of a drug.

      1996-05-14 · Taxotere (docetaxel) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-e38ed39a6944a5bd
      event date
      1996-05-14
      event kind
      accelerated-approval
      drug or regimen
      Taxotere (docetaxel)
      source indication text
      Locally advanced or metastatic breast carcinoma that progressed during anthracycline-based therapy or relapsed during anthracycline-based adjuvant therapy
      match phrase
      breast carcinoma
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-784ad31cc1e26911de81
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      1998-04-30 · Xeloda (capecitabine) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-d28c492fc3a1807f
      event date
      1998-04-30
      event kind
      accelerated-approval
      drug or regimen
      Xeloda (capecitabine)
      source indication text
      Metastatic breast cancer resistant to paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and further anthracycline therapy is contraindicated
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-202c581a375484cc6391
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      1998-06-22 · Taxotere (docetaxel) · traditional approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-d8329b64b7c25e79
      event date
      1998-06-22
      event kind
      traditional-approval
      drug or regimen
      Taxotere (docetaxel)
      source indication text
      Locally advanced or metastatic breast carcinoma that progressed during anthracycline-based therapy or relapsed during anthracycline-based adjuvant therapy
      match phrase
      breast carcinoma
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-784ad31cc1e26911de81
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2001-09-07 · Xeloda (capecitabine) · traditional approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-b705cd2385eb8b56
      event date
      2001-09-07
      event kind
      traditional-approval
      drug or regimen
      Xeloda (capecitabine)
      source indication text
      Metastatic breast cancer resistant to paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and further anthracycline therapy is contraindicated
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-202c581a375484cc6391
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2002-09-05 · Arimidex (anastrozole) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-480930fea8a51ae0
      event date
      2002-09-05
      event kind
      accelerated-approval
      drug or regimen
      Arimidex (anastrozole)
      source indication text
      Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-bd9974d00fe3063899be
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2004-10-29 · Femara (letrozole) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-6c1b243d60874939
      event date
      2004-10-29
      event kind
      accelerated-approval
      drug or regimen
      Femara (letrozole)
      source indication text
      Extended adjuvant treatment of early breast cancer in postmenopausal women who received 5 years of adjuvant tamoxifen
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-7d7e0b5accd3dbb8a76d
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2005-09-16 · Arimidex (anastrozole) · traditional approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-6d0181359a9383af
      event date
      2005-09-16
      event kind
      traditional-approval
      drug or regimen
      Arimidex (anastrozole)
      source indication text
      Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-bd9974d00fe3063899be
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2005-12-28 · Femara (letrozole) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-e45e75eb7f08bc4a
      event date
      2005-12-28
      event kind
      accelerated-approval
      drug or regimen
      Femara (letrozole)
      source indication text
      Postmenopausal women with HR positive early breast cancer
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-90c38048013f53e09335
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2008-02-22 · Avastin (bevacizumab) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-9a70a87771187a65
      event date
      2008-02-22
      event kind
      accelerated-approval
      drug or regimen
      Avastin (bevacizumab)
      source indication text
      In combination with paclitaxel for patients who have not received chemotherapy for metastatic HER2 negative breast cancer
      match phrase
      breast cancer
      match status
      candidate
      status category
      withdrawn
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-9511165d623c9cba0382
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/withdrawn-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2010-01-29 · Tykerb (lapatinib) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-453bf4887c8a82cd
      event date
      2010-01-29
      event kind
      accelerated-approval
      drug or regimen
      Tykerb (lapatinib)
      source indication text
      In combination with letrozole for post-menopausal women with HR-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-82cf35181d5af795f260
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2010-04-30 · Femara (letrozole) · traditional approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-299fad2c21e5e200
      event date
      2010-04-30
      event kind
      traditional-approval
      drug or regimen
      Femara (letrozole)
      source indication text
      Postmenopausal women with HR positive early breast cancer
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-90c38048013f53e09335
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2010-04-30 · Femara (letrozole) · traditional approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-813f33c1bbb3097e
      event date
      2010-04-30
      event kind
      traditional-approval
      drug or regimen
      Femara (letrozole)
      source indication text
      Extended adjuvant treatment of early breast cancer in postmenopausal women who received 5 years of adjuvant tamoxifen
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-7d7e0b5accd3dbb8a76d
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2011-11-18 · Avastin (bevacizumab) · withdrawal
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-b806fe8da1f663a6
      event date
      2011-11-18
      event kind
      withdrawal
      drug or regimen
      Avastin (bevacizumab)
      source indication text
      In combination with paclitaxel for patients who have not received chemotherapy for metastatic HER2 negative breast cancer
      match phrase
      breast cancer
      match status
      candidate
      status category
      withdrawn
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-9511165d623c9cba0382
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/withdrawn-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2013-09-30 · Perjeta (pertuzumab) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-3368a31ef34c1894
      event date
      2013-09-30
      event kind
      accelerated-approval
      drug or regimen
      Perjeta (pertuzumab)
      source indication text
      In combination with trastuzumab and docetaxel for neoadjuvant treatment of HER2-positive locally advanced inflammatory or early-stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early early breast cancer
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-2042250a3fdb5b1ba54d
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2015-02-03 · Ibrance (palbociclib) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-a80e503b68697372
      event date
      2015-02-03
      event kind
      accelerated-approval
      drug or regimen
      Ibrance (palbociclib)
      source indication text
      In combination with letrozole for postmenopausal women with ER-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for metastatic disease
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-f1c1411e2a103eb4331d
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2017-03-31 · Ibrance (palbociclib) · traditional approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-87e1462b06d274dc
      event date
      2017-03-31
      event kind
      traditional-approval
      drug or regimen
      Ibrance (palbociclib)
      source indication text
      In combination with letrozole for postmenopausal women with ER-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for metastatic disease
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-f1c1411e2a103eb4331d
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2017-12-20 · Perjeta (pertuzumab) · traditional approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-2b9e2c1e5af009aa
      event date
      2017-12-20
      event kind
      traditional-approval
      drug or regimen
      Perjeta (pertuzumab)
      source indication text
      In combination with trastuzumab and docetaxel for neoadjuvant treatment of HER2-positive locally advanced inflammatory or early-stage breast cancer (either greater than 2 cm in diameter or node-positive) as part of a complete treatment regimen for early early breast cancer
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-2042250a3fdb5b1ba54d
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2018-12-06 · Tykerb (lapatinib) · traditional approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-c4e6cfae42965d72
      event date
      2018-12-06
      event kind
      traditional-approval
      drug or regimen
      Tykerb (lapatinib)
      source indication text
      In combination with letrozole for post-menopausal women with HR-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-82cf35181d5af795f260
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2019-03-08 · Tecentriq (atezolizumab) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-98b25c211d8d5105
      event date
      2019-03-08
      event kind
      accelerated-approval
      drug or regimen
      Tecentriq (atezolizumab)
      source indication text
      In combination with paclitaxel protein-bound for unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering = 1% of the tumor area), as determined by an FDA-approved test.
      match phrase
      breast cancer
      match status
      candidate
      status category
      withdrawn
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-fdd6a6634a93158b671b
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/withdrawn-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2019-12-20 · Enhertu (Fam-trastuzumab deruxtecan-nxki) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-b9b393513c07e5b2
      event date
      2019-12-20
      event kind
      accelerated-approval
      drug or regimen
      Enhertu (Fam-trastuzumab deruxtecan-nxki)
      source indication text
      Adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-9296042d51d58533d9fc
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2021-10-06 · Tecentriq (atezolizumab) · withdrawal
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-c30c5f38918960a6
      event date
      2021-10-06
      event kind
      withdrawal
      drug or regimen
      Tecentriq (atezolizumab)
      source indication text
      In combination with paclitaxel protein-bound for unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering = 1% of the tumor area), as determined by an FDA-approved test.
      match phrase
      breast cancer
      match status
      candidate
      status category
      withdrawn
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-fdd6a6634a93158b671b
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/withdrawn-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2022-05-04 · Enhertu (Fam-trastuzumab deruxtecan-nxki) · traditional approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-4bf55aa1fc8f6f4b
      event date
      2022-05-04
      event kind
      traditional-approval
      drug or regimen
      Enhertu (Fam-trastuzumab deruxtecan-nxki)
      source indication text
      Adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting
      match phrase
      breast cancer
      match status
      candidate
      status category
      verified_clinical_benefit
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-9296042d51d58533d9fc
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/verified-clinical-benefit-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-01-17 · datopotamab deruxtecan-dlnk · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      notice-c47d1848e489db06
      event date
      2025-01-17
      event kind
      approval-notification
      drug or regimen
      datopotamab deruxtecan-dlnk
      source indication text
      FDA approved datopotamab deruxtecan-dlnk, a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, hormone receptor -positive, human epidermal growth factor receptor 2 -negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
      match phrase
      breast cancer
      match status
      candidate
      status category
      Source null
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-718ebee3ee60ca74
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-01-27 · fam-trastuzumab deruxtecan-nxki · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      notice-fc2e8fba5106d4f3
      event date
      2025-01-27
      event kind
      approval-notification
      drug or regimen
      fam-trastuzumab deruxtecan-nxki
      source indication text
      FDA approved fam-trastuzumab deruxtecan-nxki for unresectable or metastatic hormone receptor -positive, HER2-low or HER2-ultralow breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
      match phrase
      breast cancer
      match status
      candidate
      status category
      Source null
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-6c8690a10014b840
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-hr-positive-her2-low-or-her2
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-09-25 · imlunestrant · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      notice-0b162a998d6a5e47
      event date
      2025-09-25
      event kind
      approval-notification
      drug or regimen
      imlunestrant
      source indication text
      FDA approved imlunestrant, an estrogen receptor antagonist, for adults with estrogen receptor -positive, human epidermal growth factor 2 -negative, estrogen receptor-1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
      match phrase
      breast cancer
      match status
      candidate
      status category
      Source null
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-e6329c4a9f1a5704
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-imlunestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2025-12-15 · fam-trastuzumab deruxtecan-nxki with pertuzumab · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      notice-bcd1c984343331ac
      event date
      2025-12-15
      event kind
      approval-notification
      drug or regimen
      fam-trastuzumab deruxtecan-nxki with pertuzumab
      source indication text
      FDA approved fam-trastuzumab deruxtecan-nxki in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer as determined by an FDA-approved test.
      match phrase
      breast cancer
      match status
      candidate
      status category
      Source null
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-838a85e7ab9c5846
      source url
      https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-fam-trastuzumab-deruxtecan-nxki-pertuzumab-unresectable-or-metastatic-her2-positive
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2026-05-01 · vepdegestrant · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      notice-def544a6d91f534e
      event date
      2026-05-01
      event kind
      approval-notification
      drug or regimen
      vepdegestrant
      source indication text
      FDA approved vepdegestrant, a heterobifunctional protein degrader, for adults with estrogen receptor -positive, human epidermal growth factor receptor 2 -negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
      match phrase
      breast cancer
      match status
      candidate
      status category
      Source null
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-139bc569cd69b40c
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-vepdegestrant-er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2026-05-15 · fam-trastuzumab deruxtecan-nxki · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      notice-98e9bd699133ea26
      event date
      2026-05-15
      event kind
      approval-notification
      drug or regimen
      fam-trastuzumab deruxtecan-nxki
      source indication text
      FDA approved fam-trastuzumab deruxtecan-nxki for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for T-DXd followed by a taxane, trastuzumab, and pertuzumab, for the neoadjuvant treatment of adult patients with HER2-positive Stage II or III breast cancer, as determined by an FDA-authorized test. The second indication is for T-DXd for the adjuvant treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab and taxane-based treatment.
      match phrase
      breast cancer
      match status
      candidate
      status category
      Source null
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-a25466af65cfcdc1
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2026-05-22 · datopotamab deruxtecan-dlnk · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      notice-4e4bb7b26ead1f4e
      event date
      2026-05-22
      event kind
      approval-notification
      drug or regimen
      datopotamab deruxtecan-dlnk
      source indication text
      FDA approved datopotamab deruxtecan-dlnk for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.
      match phrase
      breast cancer
      match status
      candidate
      status category
      Source null
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-06e75bbbea9cc2b5
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2026-06-24 · sacituzumab govitecan-hziy · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      notice-751ba0fbc8cc4d64
      event date
      2026-06-24
      event kind
      approval-notification
      drug or regimen
      sacituzumab govitecan-hziy
      source indication text
      FDA approved sacituzumab govitecan-hziy for two indications in adults with triple-negative breast cancer . The first indication, supported by ASCENT-03, is for sacituzumab govitecan-hziy as a single agent for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. The second indication, supported by ASCENT-04/KEYNOTE D-19, is for sacituzumab govitecan-hziy in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 as determined by an FDA-authorized test.
      match phrase
      breast cancer
      match status
      candidate
      status category
      Source null
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-49e2a73345425f2f
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2026-06-24 · palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      notice-77f70ab5f14159d8
      event date
      2026-06-24
      event kind
      approval-notification
      drug or regimen
      palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy
      source indication text
      FDA approved palbociclib in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
      match phrase
      breast cancer
      match status
      candidate
      status category
      Source null
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-679b968656ef28cf
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2026-07-14 · gedatolisib with fulvestrant, with or without palbociclib · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      notice-95a1c2aa93f1fd39
      event date
      2026-07-14
      event kind
      approval-notification
      drug or regimen
      gedatolisib with fulvestrant, with or without palbociclib
      source indication text
      FDA approved gedatolisib in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor -positive, human epidermal growth factor receptor 2 -negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
      match phrase
      breast cancer
      match status
      candidate
      status category
      Source null
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-cfcc707359fdc22f
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2026-09-04 · Etcamah (camizestrant) · accelerated approval
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      fda-e2bb1179d3531239
      event date
      2026-09-04
      event kind
      accelerated-approval
      drug or regimen
      Etcamah (camizestrant)
      source indication text
      In combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test
      match phrase
      breast cancer
      match status
      candidate
      status category
      ongoing
      has date discrepancy
      0
      source collection
      fda-status-row
      source key
      fda-aa-086f7c231b1cbc70103f
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      2026-09-04 · camizestrant with a CDK4/6 inhibitor · approval notification
      release id
      clinical-indications-draft-1
      disease state id
      ds-breast-cancer
      event id
      notice-17b005184d4e1293
      event date
      2026-09-04
      event kind
      approval-notification
      drug or regimen
      camizestrant with a CDK4/6 inhibitor
      source indication text
      FDA approved camizestrant, an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor for adults with hormone receptor -positive, human epidermal growth factor receptor 2 -negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.
      match phrase
      breast cancer
      match status
      candidate
      status category
      accelerated
      has date discrepancy
      0
      source collection
      fda-approval-notice
      source key
      fda-29ff88a8fe51d0cc
      source url
      https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negative
      curation status
      draft
      reviewed by
      Source null
      reviewed at
      Source null
      created at
      2026-09-10T00:00:00Z
      Original event source →
      Source relationships and population-mapping limitations
      bindings
      1. release id
        clinical-indications-draft-1
        disease state id
        ds-breast-cancer
        binding id
        ncit-C118809
        source collection
        ncit-concept
        source key
        C118809
        source excerpt
        Source null
        match status
        ambiguous
        match note
        Resolution status: ambiguous.
        recorded at
        2026-09-10T00:00:00Z
      2. release id
        clinical-indications-draft-1
        disease state id
        ds-breast-cancer
        binding id
        ncit-C4872
        source collection
        ncit-concept
        source key
        C4872
        source excerpt
        Source null
        match status
        ambiguous
        match note
        Resolution status: ambiguous.
        recorded at
        2026-09-10T00:00:00Z
      3. release id
        clinical-indications-draft-1
        disease state id
        ds-breast-cancer
        binding id
        ncit-C9335
        source collection
        ncit-concept
        source key
        C9335
        source excerpt
        Source null
        match status
        ambiguous
        match note
        Resolution status: ambiguous.
        recorded at
        2026-09-10T00:00:00Z
      mappings

        Download this complete draft source relationship record →

        Preserved source evidence · Not medical advice